Efficacy and Tolerability of Saxagliptin add-on Compared... | NCT01006590

Name	Class
Bristol-Myers Squibb	INDUSTRY

Efficacy and Tolerability of Saxagliptin add-on Compared... | NCT01006590 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental	Saxagliptin 5 mg	Drug: Saxagliptin
2	Active Comparator	Metformin 500 -1000 mg	Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug	5 mg, oral tablet, once daily	1	Onglyza

Outcomes Module

Measure	Description	Time Frame
Absolute Change From Baseline in HbA1c at Week 24		Baseline and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%	Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent	24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Brussels (woluwe-st-lambert)	Belgium		Belgium
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23020253	Derived	Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
FG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0013 subjects
Death		FG0001 subjects FG0011 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects
Protocol Violation		FG0001 subjects FG0010 subjects
Withdrawal by Subject		FG0004 subjects FG0012 subjects
Study specific discontinuation criteria		FG00016 subjects FG00123 subjects
Other		FG0003 subjects FG0012 subjects

Arm/Group Information

ID	Title	Description
BG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
BG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-0.47± 0.06 OG001-0.38± 0.06

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%	ANCOVA	With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment	0.26		Mean Difference (Net)	-0.10	Standard Error of the Mean	0.09	2-Sided	95	-0.26	0.07				No

Secondary

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%

Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent

Posted

Nov 2011

Number

Percentage of patients

24 Weeks

ID	Title	Description
OG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
OG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%

Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent

Posted

Nov 2011

Number

Percentage of patients

24 Weeks

ID	Title	Description
OG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
OG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 24 in Fasting Plasma Glucose

Posted

Nov 2011

Mean

Standard Error

millimol/Liter

Baseline and 24 weeks

ID	Title	Description
OG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
OG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Units	Counts
Participants	OG000146

Secondary

Change From Baseline to Week 24 in Fasting Insulin

Posted

Nov 2011

Mean

Standard Error

microUnit/milliLiter

Baseline and 24 weeks

ID	Title	Description
OG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
OG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Units	Counts
Participants	OG000146

Secondary

Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta

Posted

Nov 2011

Mean

Standard Error

Percent (%)

Baseline and 24 weeks

ID	Title	Description
OG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
OG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Saxagliptin	Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day			6	147	27	147
EG001	Metformin Uptitration	Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day			6	139	22	139

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Atrioventricilar Block Second Degree	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Tongue Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Nerve Root Compression	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Aortic Dissection	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected147 at risk EG0010 affected139 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected147 at risk EG0011 affected139 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected147 at risk EG00117 affected139 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0008 affected147 at risk EG0012 affected139 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00010 affected147 at risk EG0013 affected139 at risk

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.3202		Mean Difference (Net)	5.8	Standard Error of the Mean	5.79	2-Sided	95	-5.6	17.1				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.6203		Mean Difference (Net)	2.3	Standard Error of the Mean	4.58	2-Sided	95	-6.7	11.3				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.7627		Mean Difference (Net)	0.07	Standard Error of the Mean	0.23	2-Sided	95	-0.38	0.52				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.7701		Mean Difference (Net)	0.3	Standard Error of the Mean	1.19	2-Sided	95	-2.0	2.7				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.5882		Mean Difference (Net)	2.39	Standard Error of the Mean	4.34	2-Sided	95	-6.22	10.93				No	Superiority or Other

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals